TOLER-ENT Study: A Study to Investigate the Tolerance of the High Energy, High Protein Formula Sondalis® HP 2 kcal

Société des Produits Nestlé (SPN)17 enrolled

Overview

A multicentre, prospective, open-label, single arm study for 2 months, involving adult patients under poorly tolerated Home Enteral Nutrition (HEN). The study aims to analyse the evolution of tolerance and quality of life of HEN patients after switching from a High Protein High Energy (HPHE) polymeric Enteral Nutrition (EN) formula with or without fibre to Sondalis® HP 2kcal, with or without fibre. Eligible patients will give their written consent to participate before being included into the study.

Study Type

INTERVENTIONAL

Allocation

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Malnutrition

Interventions

Sondalis® HP 2 kcal (with or without fibre)DIETARY_SUPPLEMENT

The participants will take the study product during the two months of the study.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Men or women aged ≥18 years, * Being under EN with polymeric HPHE product with or without fibre (=HPHE), * Stable caloric prescription during HEN for at least one month, * Patient with at least a score of 2 on at least 1 item of tolerance questionnaire, * Investigators' judgement to change to HPHE concentrated, * HEN is planned for ≥ 8 weeks, * Life expectancy ≥ 3 months. * Patient or his/her primary caregiver was required to be able to understand the study and to be fully free to participate in it, * Patient having signed an informed consent, * Patient registered with a social security scheme, * Patient willing to adhere to study procedures, Exclusion Criteria: * Pregnancy or breastfeeding, * Being either under PN or ONS, * Acute intestinal disease such as gastric ulcer, gastritis, gastroparesis, * Patient under prokinetic agents during the study phase, * Patient receiving antibiotic, chemotherapy in the 7 days prior to inclusion, * Patient receiving radiation treatment except head and neck location, * Patient expected to receive chemotherapy or radiation treatment during the study except head and neck location , * Severe infectious disease and/or fever \> 38,5°C, * Emergent hospitalization within last month, * Known allergy or intolerance to any of the Sondalis® HP 2kcal with or without fibre ingredients, * Previous treatment with HPHE concentrated at home (2kcal), * Current participation in another intervention study or participation in a previous study for which exclusion period applies. * Non-compliance with prescription and administration modalities as suspected by investigator and/or by home care provider dietitian

Locations (2)

Hôpital Claude Huriez

Lille, France

Hôpital de l'Archet

Nice, France

Outcomes

Primary Outcomes

Evaluation tolerance from baseline after 2 months: Total Score

The digestive tolerance of enteral nutrition is assessed using a patient reported outcomes (PRO) questionnaire designed by clinicians. The questionnaire is composed of 9 items corresponding to the most frequent symptoms: gastro-oesophageal reflux, nausea, vomiting, feeling of an overfull stomach, bloating, flatulence, stomach pain, constipation, diarrhea. Each item includes questions relating to the frequency and impact of the symptom on daily life.

Time frame: 60 days

Secondary Outcomes

Evaluation of Tolerance from baseline to one month and from one month to two months: Total Score

Same PRO than above

Time frame: 60 days

Evaluation of Tolerance at baseline,one and two months: for each Items

Same PRO than above

Time frame: 60 days

Evolution of quality of life

The quality of life is assessed with the NutriQoL® score described by Bischoff et al (Bischoff et al, 2020). The evolution of quality of life is evaluated between baseline, 1 month and 2 months after administration of the intervention. The NutriQoL® questionnaire is a specific tool to measure HRQoL in patients receiving HEN regardless of the underlying disease and the route of administration. It consists of 17 items grouped in two dimensions, which assess physical functioning, and activities of daily living and aspects of social life.

Time frame: 60 days

Evolution of anthropometric measures: handgrip test

The anthropometric measures are assessed with the handgrip test as recommended by SFNCM (Bossu-Estour et al, 2021). The evolution of anthropometric measures is evaluated between baseline, 1 month and 2 months after administration of the intervention. The Handgrip Test uses the Hand Grip Jamar® hydraulic hand dynamometers and the measurements are carried out according to the recommendations published by the "Comité Educationnel et de Pratique Clinique" of the SFNCM.

Data from ClinicalTrials.gov

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